The efficacy of Zonisamide for BPSD in Dementia with Lewy bodies

The efficacy of Zonisamide for BPSD in Dementia with Lewy bodies - DLB-Z

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000027312

Enrollment

Registered

2017-05-12

Start date

2017-02-07

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dementia with Lewy bodies

Interventions

excegran(zonisamide)powdered + lactose lactose

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1 Probable DLB with the criteria of DLB workshop 2005 2 BPSD is present on NPI 3 MMSE score 10 26 4 WBC platelet Serum AST ALT ALP GTP level should be in normal range 5 Have a study partner able to provide an independent evaluation of functioning 6 Agreement to sign an informed consent

Exclusion criteria

Exclusion criteria: 1 Patient with non DLB. 2 No focal lesion exists in brain MRI. 3 Has current serious illness, psychiatric problem or drug abuse. 4 Those who have used Zonisamide over before. 5 Those who have joined any clinical trial within 3 month. 6 Those who have received medications that affected the central nervous system within 4 weeks. 7 Dose of chronic medications that affect CNS should be stable for at least 4 weeks before Visit0. 8 Those who are judged inadequate by their doctor.

Design outcomes

Primary

Measure	Time frame
Neuropsychiatric Inventory	—

Secondary

Measure	Time frame
Mini Mental State Examination Cognitive Fluctuation Inventory Unified parkinson's Disease Rating Scale part3 Rescue medicine	—

Countries

Japan

Contacts

Public ContactMayumi Maeda

Clinical Research Network for Dementia Innovation Center for Clinical Research

crndinfo@ncgg.go.jp0562-46-2311

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026